ASPIRIN- aspirin tablet 
America Medic & Science

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Aspirin 81 mg Low Dose
Safety Coated Aspirin 

Drug Facts

Active ingredient (in each tablet)

Aspirin, 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you:

Do not use if you are allergic to aspirin or any other pain reliever/ fever reducer.

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complictions during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use this product if printed safety seal under cap is torn or missing.

Aspirin is not appropriate for everyone, so be sure to talk to your doctor before you begin an aspiring regimen.

Directions

Directions

Other information

anhydrous lactose, carnauba wax, iron oxide ochre, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch

Questions or comments?

call 1-855-314-1850

NDC 49638-481-36

label

ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49638-481
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize8mm
FlavorImprint Code AP;121
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49638-481-36365 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/18/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34301/18/2017
Labeler - America Medic & Science (071065464)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC037052099manufacture(49638-481)

Revised: 1/2017
Document Id: af54c8ac-4bff-4152-8577-d69dcdbc02c4
Set id: fb3cfd33-3942-4371-b86a-b3c3ea1dceb9
Version: 1
Effective Time: 20170118
 
America Medic & Science